Guidance Documents

The following documents provide investigators with information that will be helpful for meeting the standards set by the CU Boulder IRB and by the Federal Regulations for the protection of human subjects in research. Additional topics will be added on an ongoing basis.

• Adverse Event Determination and Reporting
  Information regarding identifying adverse events and reporting requirements. 
• Advertising and Recruitment
  Guidelines for ads used in recruitment.
• Certificates of Confidentiality
  Information regarding NIH Policy for issuance of Certificates of Confidentiality.
• Classroom Research Projects
  What should I consider before conducting classroom research?
• Data Security
  Guidelines for how to ensure confidentiality of subjects' data and manage data in accordance with CU Boulder Policy.
• Deception and Incomplete Disclosure
  Giving false information and withholding information from research participants.
• Focus Groups
  What should I consider when designing a focus group protocol?
• GDPR
  A privacy act in the European Union (EU) and European Economic Area (EEA) countries which regulates the collection, use, and security of personal data. Research conducted in these locations or with persons in those locations are subject to this regulation.
• HRP-104: BROCHURE - Should I Take Part In Research?
  Some things you should know before deciding to participate in research.
• Investigational Device Studies
  Information for investigators to follow in determining whether a study falls under FDA Device Regulations for IRB review and oversight.
• IRB Authorization Agreement Guidance
  What is an IAA? How can I apply for an IAA?
• NIH Human Research Resource Sheet
  A one page resource sheet put together by the NIH to help find the information needed to develop NIH funded proposals involving human subjects research.
• Research in K-12 Schools
  Guidance for PIs conducting research in the public school system.
• Research involving Marijuana/Cannabis
  Guidance for PIs conducting research involving marijuana.
• Standards and Language for Studies Involving MRI
  Protocol standards and language, consent form example language.
• Students as Research Subjects: How to Avoid Undue Influence and Coercion
  Guidance explaining how one may avoid undue influence and coercion when using students as research subjects.
• Waiver of Written Documentation of Informed Consent and Verbal Consent
  How to get verbal (oral) consent in place of written consent.
• Waiver of Informed Consent
  Guidance for requesting a Waiver of some or all elements of Informed Consent.